Trial Outcomes & Findings for A Trial of Rosiglitazone for Ulcerative Colitis (NCT NCT00065065)

NCT ID: NCT00065065

Last Updated: 2018-01-16

Results Overview

Mayo score decrease \>=2 points adjusted for age and smoking status.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 105 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2018-01-16

Participant Flow

Patients were recruited from 15 clinical centers between September 6, 2002 and January 11, 2006.

Participant milestones

Measure	Rosiglitazone rosiglitazone (Avandia): 4mg orally twice daily for 12 weeks	Placebo Placebo identical to study drug twice daily for 12 weeks
Overall Study STARTED	52	53
Overall Study COMPLETED	42	33
Overall Study NOT COMPLETED	10	20

Reasons for withdrawal

Measure	Rosiglitazone rosiglitazone (Avandia): 4mg orally twice daily for 12 weeks	Placebo Placebo identical to study drug twice daily for 12 weeks
Overall Study Adverse Event	3	2
Overall Study Withdrawal by Subject	1	5
Overall Study Lack of Efficacy	4	11
Overall Study Other	2	2

Baseline Characteristics

A Trial of Rosiglitazone for Ulcerative Colitis

Baseline characteristics by cohort

Measure	Rosiglitazone n=52 Participants rosiglitazone (Avandia): 4mg orally twice daily	Placebo n=53 Participants Identical in appearance to study drug taken twice a day	Total n=105 Participants Total of all reporting groups
Race (NIH/OMB) White	48 Participants n=5 Participants	50 Participants n=7 Participants	98 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	42 years n=5 Participants	46 years n=7 Participants	43 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	34 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants	53 participants n=7 Participants	105 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Mayo score decrease >=2 points adjusted for age and smoking status.

Outcome measures

Measure	Rosiglitazone n=52 Participants rosiglitazone (Avandia): 4mg orally twice daily	Placebo n=53 Participants Identical in appearance to study drug taken twice a day
Number of Participants With Improvement of Signs and Symptoms of UC at 12 Weeks	23 participants	12 participants

SECONDARY outcome

Timeframe: 12 weeks

Mayo Score <=2 at 12 weeks post intervention

Outcome measures

Measure	Rosiglitazone n=52 Participants rosiglitazone (Avandia): 4mg orally twice daily	Placebo n=53 Participants Identical in appearance to study drug taken twice a day
Number of Participants With Clinical Remission at 12 Weeks	9 participants	1 participants

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Rosiglitazone n=52 Participants rosiglitazone (Avandia): 4mg orally twice daily	Placebo n=53 Participants Identical in appearance to study drug taken twice a day
Number of Participants With Endoscopic Remission at 12 Weeks	4 Participants	1 Participants

Adverse Events

Rosiglitazone

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rosiglitazone n=52 participants at risk rosiglitazone (Avandia): 4mg orally twice daily	Placebo n=53 participants at risk Identical in appearance to study drug taken twice a day
Gastrointestinal disorders Worsening colitis requiring hospitalization and/or colectomy	1.9% 1/52 • Number of events 1	7.5% 4/53 • Number of events 4
Gastrointestinal disorders Bleeding after sigmoidoscopy biopsy	0.00% 0/52	1.9% 1/53 • Number of events 1
Psychiatric disorders Depression	1.9% 1/52 • Number of events 1	0.00% 0/53

Other adverse events

Measure	Rosiglitazone n=52 participants at risk rosiglitazone (Avandia): 4mg orally twice daily	Placebo n=53 participants at risk Identical in appearance to study drug taken twice a day
General disorders Edema	17.3% 9/52	1.9% 1/53
General disorders Fatigue	7.7% 4/52	5.7% 3/53
General disorders Fever	5.8% 3/52	3.8% 2/53
General disorders Constitutional symptoms-other	9.6% 5/52	5.7% 3/53
Skin and subcutaneous tissue disorders Dermatologic skin - other	1.9% 1/52	5.7% 3/53
Gastrointestinal disorders Colitis	7.7% 4/52	11.3% 6/53
Gastrointestinal disorders Diarrhea	5.8% 3/52	13.2% 7/53
Gastrointestinal disorders Vomiting	5.8% 3/52	3.8% 2/53
Gastrointestinal disorders Gastrointestinal - other	11.5% 6/52	15.1% 8/53
Infections and infestations Infection	9.6% 5/52	5.7% 3/53
Musculoskeletal and connective tissue disorders Musculoskeletal - other	9.6% 5/52	1.9% 1/53
Gastrointestinal disorders Abdominal pain and cramping	7.7% 4/52	3.8% 2/53
Musculoskeletal and connective tissue disorders Arthralgia	5.8% 3/52	3.8% 2/53
General disorders Chest pain	5.8% 3/52	1.9% 1/53
Nervous system disorders Headache	19.2% 10/52	13.2% 7/53
Musculoskeletal and connective tissue disorders Myalgia	7.7% 4/52	0.00% 0/53
General disorders Pain - other	11.5% 6/52	11.3% 6/53
Respiratory, thoracic and mediastinal disorders Cough	5.8% 3/52	5.7% 3/53
Renal and urinary disorders Proteinuria	5.8% 3/52	5.7% 3/53
Investigations Decrease in hemoglobin concentration by 2 g/dL	7.7% 4/52	7.5% 4/53

Additional Information

James D. Lewis, MD, MSCE

University of Pennsylvania

Phone: 215-573-5137

Email: lewisjd@mail.med.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place